ERVEBO (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification - Seite 3

Arthralgia was reported to occur in 7% to 40% of vaccine recipients in blinded, placebo-controlled studies. Severe arthralgia, defined as preventing daily activity, was reported in up to 3% of subjects.

Arthritis (including events of arthritis, joint effusion, joint swelling, osteoarthritis, monoarthritis or polyarthritis) was reported to occur in 0% to 24% of subjects in blinded, placebo-controlled studies in which subjects received ERVEBO or a lower dose formulation, with all but one study reporting arthritis in <5% of subjects. Most occurrences of arthritis were reported within the first few weeks following vaccination, were of mild to moderate intensity, and resolved within several weeks after onset. In one study conducted in Switzerland (Study 5, NCT02287480), 102 subjects received ERVEBO or a lower dose formulation. In this study, arthritis was reported to occur in 24% of subjects and severe arthritis, defined as preventing daily activity, in 12% of subjects.

Rash was reported to occur after administration of ERVEBO in blinded, placebo-controlled studies, with all but one study reporting rash in <9% of subjects. In Study 5, rash was reported to occur in 25% (n=4) of ERVEBO recipients and 7.7% (n=1) of placebo recipients.

White blood cell counts were assessed in 697 subjects who received ERVEBO. Decreases in lymphocytes were reported in up to 85% of subjects and decreases in neutrophils were reported in up to 43% of subjects. No associated infections were reported.

Among 15,399 ERVEBO recipients, two serious adverse reactions of pyrexia were reported as vaccine-related. In addition, two serious adverse reactions of anaphylaxis were reported as vaccine-related. None of these serious adverse reactions were fatal.

DRUG INTERACTIONS

Interference with Laboratory Tests

Following vaccination with ERVEBO, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens. GP-based testing may have limited diagnostic value during the period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no adequate and well-controlled studies of ERVEBO in pregnant women, and human data available from clinical trials with ERVEBO are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.

The decision to vaccinate a woman who is pregnant should consider the woman’s risk of exposure to Zaire ebolavirus.

Lactation

Human data are not available to assess the impact of ERVEBO on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ERVEBO and any potential adverse effects on the breastfed child from ERVEBO or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine.